MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problems Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During a premature ventricular contraction procedure, an intellamap orion catheter was selected for use.It was reported that the physician had inserted the orion in the left ventricle by a retro aortic approach.Once in the left ventricle, she noticed she could not deploy the orion completely, with the deployment slider at the maximum deployment state on the handle.The orion was not fully deployed on the fluoroscopy and rhythmia.She took the orion out of the patient and noticed that an abnormal metallic part was attached to the orion.The catheter was exchanged for a new one to complete the case.No patient complications were reported.

Event Description

During a premature ventricular contraction procedure, an intellamap orion catheter was selected for use.It was reported that the physician had inserted the orion in the left ventricle by a retro aortic approach.Once in the left ventricle, she noticed she could not deploy the orion completely, with the deployment slider at the maximum deployment state on the handle.The orion was not fully deployed on the fluoroscopy and rhythmia.She took the orion out of the patient and noticed that an abnormal metallic part was attached to the orion.The catheter was exchanged for a new one to complete the case.No patient complications were reported.It was further reported that the patient did not have any metal implants such as a stent or prosthetic heart valve.Also, no sheath was used with the orion.The orion was only inserted through a 9fr introducer, that was inspected after the case and seemed fine, and was not damaged.Additionally, the introducer was made only of plastic, it was not braided, and there were no metallic parts in it.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During a premature ventricular contraction procedure, an intellamap orion catheter was selected for use.It was reported that the physician had inserted the orion in the left ventricle by a retro aortic approach.Once in the left ventricle, she noticed she could not deploy the orion completely, with the deployment slider at the maximum deployment state on the handle.The orion was not fully deployed on the fluoroscopy and rhythmia.She took the orion out of the patient and noticed that an abnormal metallic part was attached to the orion.The catheter was exchanged for a new one to complete the case.No patient complications were reported.It was further reported that the patient did not have any metal implants such as a stent or prosthetic heart valve.Also, no sheath was used with the orion.The orion was only inserted through a 9fr introducer, that was inspected after the case and seemed fine, and was not damaged.Additionally, the introducer was made only of plastic, it was not braided, and there were no metallic parts in it.

Manufacturer Narrative

The device was received at boston scientific for analysis.Visual inspection of the returned orion catheter revealed no issues.During an attempt to deploy the catheter, the catheter did not fully deploy.Testing with a rhythmia hdx system was performed, and the device was unexpired with no errors.Deployment did show on the workstation screen, and there were 100% mapping capabilities.The reported abnormal metallic material was not sent back with the device.There were no signs of damage or material origination.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15822007
• MDR Text Key: 307009317
• Report Number: 2124215-2022-47226
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0029535347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1